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Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia

16. marts 2011 opdateret af: Mayo Clinic

Phase II Study of the Combination of Low-Dose Thalidomide, Prednisone, and Oral Cyclophosphamide ("TPC") in the Therapy of Myelofibrosis With Myeloid Metaplasia (MMM)

RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia.

PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

  • Determine the benefit of thalidomide, prednisone, and cyclophosphamide in alleviating disease-associated anemia, thrombocytopenia, and/or splenomegaly in patients with myelofibrosis with myeloid metaplasia (MMM).
  • Determine the benefit of this regimen in palliating four hypercatabolic constitutional symptoms (i.e., weight loss, fatigue, drenching night sweats, and unexplained fevers) in these patients.
  • Determine the toxicity profile of this regimen in these patients.

Secondary

  • Determine the effect of this regimen on leukocyte count.
  • Determine the effect of this regimen on bone marrow histology, including microvessel density and reticulin fibrosis.
  • Determine the effect of this regimen on intramedullary and urinary markers of angiogenesis.
  • Determine the effect of this regimen on circulating myeloid progenitor cells by quantifying CD34+ cells.

OUTLINE: Patients receive oral thalidomide, oral prednisone, and oral cyclophosphamide (TPC) once daily on days 1-28. Treatment repeats every 28 days for 3 courses. After 3 courses (3 months) of treatment, patients who respond to TPC therapy may receive oral thalidomide alone once daily for up to 3 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspirate and biopsy prior to study entry, 6 months after starting therapy, and then every 6 months for up to 3 years. Samples are analyzed by microvessel density/angiogenesis studies (i.e., CD34 immunohistochemical and vascular endothelium-specific staining) to determine the effect of therapy on markers of bone marrow angiogenesis.

After completion of study therapy, patients are followed every 6 months for up to 3 years.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

22

Fase

  • Fase 2

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

DISEASE CHARACTERISTICS:

  • Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes:

    • Agnogenic myeloid metaplasia
    • Post-polycythemic myeloid metaplasia
    • Post-thrombocythemic myeloid metaplasia

  • Must have 1 of the following MMM-related conditions:

    • Anemia, defined as hemoglobin < 10 g/dL

      • Iron deficiency must be excluded as cause
    • Thrombocytopenia, defined as platelet count < 100,000/mm³
    • Palpable hepatomegaly or splenomegaly

  • No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following:

    • Metastatic carcinoma
    • Lymphoma
    • Myelodysplasia
    • Hairy cell leukemia
    • Mast cell disease
    • Acute leukemia (including M7 type)
    • Acute myelofibrosis
  • No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Absolute neutrophil count ≥ 750/mm³
  • Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM
  • AST ≤ 5 times ULN, unless elevation due to MMM
  • Creatinine ≤ 2.5 mg/dL

  • No uncontrolled infection, including tuberculosis

    • No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy

      • Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed
  • No federal medical center inmates or other incarcerated patients
  • No peripheral neuropathy ≥ grade 2
  • No comorbid condition in which the use of study therapy is felt to be potentially harmful
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception

PRIOR CONCURRENT THERAPY:

  • No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days
  • Prior splenectomy for MMM allowed
  • No concurrent hematopoietic growth factors

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)

Sekundære resultatmål

Resultatmål
Tid til progression
Progressionsfri overlevelse
Samlet overlevelse
Varighed af svar
Constitutional symptom status and bone marrow morphology
Toxicity as measured by NCI CTC v 2.0

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mayo Clinic

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Studiestol: Ruben A. Mesa, MD, Mayo Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2004

Primær færdiggørelse (Faktiske)

1. oktober 2006

Studieafslutning (Faktiske)

1. oktober 2006

Datoer for studieregistrering

Først indsendt

7. marts 2007

Først indsendt, der opfyldte QC-kriterier

7. marts 2007

Først opslået (Skøn)

9. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. marts 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. marts 2011

Sidst verificeret

1. marts 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000530973
  • P30CA015083 (U.S. NIH-bevilling/kontrakt)
  • MC028A (Anden identifikator: Mayo Clinic Cancer Center)
  • 1360-03 (Anden identifikator: Mayo Clinic IRB)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med cyclophosphamid

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

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Placeringer

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